The U.S. Food & Drug Administration (FDA) announced in a news release dated April 29, 2014 that it would put forth two orders relating to transvaginal mesh used to treat women with pelvic organ prolapse (POP). The two orders have not been made final, and the FDA is accepting feedback on their propositions over a three month period.
One of the orders recommends updating the classification of transvaginal mesh for POP so that it accurately reflects the health risks caused by these medical devices. In their April news release, the FDA advises that transvaginal mesh be classified as class III, meaning that it is a high-risk device. The FDA currently classifies transvaginal mesh for POP as a class II device, which denotes that the device poses a moderate risk to the patient’s health and safety.
A number of the transvaginal mesh products that have been sold in the U.S. were brought to market using an expedited FDA approval process known as the 510(k) application. Medical device manufacturers, such as Johnson & Johnson and their subsidiary Ethicon, use the 510(k) process to introduce new products onto the market that are updated versions of an FDA approved device. In some cases, due to similarities between two products, companies do not submit extensive safety information.
Now that transvaginal mesh injuries have become evident, the FDA proposes that any new transvaginal mesh products seeking approval to treat POP must submit a premarket approval application. This application would require manufacturers to collect and submit thorough data about the new product from a premarket clinical trial.
Transvaginal mesh injuries can be life-changing. Our attorneys recognize the pain and suffering endured by women and families impacted by transvaginal mesh.
The defective medical device lawyers at Carey Danis & Lowe represent individuals and families who have been negatively impacted by certain medical devices, including transvaginal mesh. We are currently investigating transvaginal mesh cases. If you have been injured by mesh, Carey Danis & Lowe encourages you to begin exploring your legal options and compensation eligibility. We offer free initial case evaluations.
Share your transvaginal mesh story with Carey Danis & Lowe today by calling 800.721.2519, or by completing one of our personal injury claim forms.References: Defective Medical Device litigation, Product Liability, Transvaginal Mesh